LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201127
    Device Name
    DEFEND Ear-loop Face Masks
    Manufacturer
    Young Dental Manufacturing Co. 1, LLC
    Date Cleared
    2021-04-14

    (351 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K160269
    Why did this record match?
    Device Name :

    DEFEND Ear-loop Face Masks

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DEFEND Ear-Loop Face Masks are intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

    Device Description

    The DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user). The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection.

    AI/ML Overview

    The provided document describes the K201127 submission for DEFEND Ear-loop Face Masks, a Class II surgical mask. The information focuses on non-clinical performance testing against ASTM F2100 standards to demonstrate substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on your requested categories:

    1. A table of acceptance criteria and the reported device performance

    MethodologyPurposeAcceptance Criteria (AQL = 4.0%)Reported Device Performance (Results)
    ASTM F1862Determine synthetic blood penetration resistance29/32 pass at 160 mmHg32/32 Pass per lot at 160 mmHg
    ASTM F2101Determine the bacterial filtration efficiency≥ 98%32/32 Pass per lot, Average = 99.8%
    ASTM F2299Determine sub-micron particulate filtration efficiency≥ 98%32/32 Pass per lot, Average = 99.7%
    MIL-M-36954C or EN 14683 Annex CDetermine breathing resistance or differential pressure
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1